Advanced Sterilization Products Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator
Brand
Advanced Sterilization Products
Lot Codes / Batch Numbers
CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436, 9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743, 9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985, 10019, 10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321, 8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631, 8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797, 8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272 CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421, 8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274, 9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000
Products Sold
CIDEX OPA code 20392, lots: 9272, 9273, 9433, 9434, 9436, 9461, 9512, 9513, 9537, 9538, 9578, 9593, 9664, 9699, 9743, 9744, 9745, 9746, 9814, 9815, 9816, 9854, 9935, 9984, 9985, 10019, 10028, 10036, 10037, 8101, 8144, 8218, 8233, 8321, 8482, 8483, 8510, 8511, 8512, 8513, 8514, 8618, 8630, 8631, 8632, 8636, 8637, 8638, 8792, 8793, 8794, 8795, 8796, 8797, 8798, 8978, 8980, 8981, 9130, 9131, 9133, 9270, 9271, 9272 CIDEX OPA code 20393, lots: 8079, 8102, 8219, 8223, 8421, 8456, 8515, 8550, 8633, 8639, 8970, 8982, 9075, 9260, 9274, 9275, 9536, 9564, 9663, 9796, 9907, 9908, 10000
Advanced Sterilization Products is recalling Ortho-phthaladehyde Concentration Indicator Browne CIDEX OPA Indicator due to Performance failure complaints.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Performance failure complaints.
Recommended Action
Per FDA guidance
Firm issued a Safety Alert to inform users to perform a daily Quality Control check of the test strips to ensure that they are working.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026